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Single Ventricle Heart Disease clinical trials

View clinical trials related to Single Ventricle Heart Disease.

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NCT ID: NCT05918211 Recruiting - Clinical trials for Single Ventricle Heart Disease

Fontan Udenafil Exercise Longitudinal Assessment Trial - 2

FUEL-2
Start date: October 30, 2023
Phase: Phase 3
Study type: Interventional

This study will evaluate the clinical efficacy and safety of udenafil, an orally administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of adolescent who have had the Fontan procedure.

NCT ID: NCT05199857 Recruiting - Frailty Clinical Trials

WE BEAT - HEART Club Fontan Wellness Project: A Virtual Resilience Promotion and Frailty Prevention Program

Start date: March 30, 2022
Phase: N/A
Study type: Interventional

This trial is being conducted to evaluate the effect of a small-group wellness education program combined with a longitudinal, individualized prescription exercise program on the wellness, resiliency, and daily activity levels of pediatric patients with Fontan physiology. There will be two phases for this project. The first phase is the "WE BEAT Group Wellness Education Program" and participants will be transitioned into the phase two HEART Club following phase one. The trial will look at feasibility and acceptability of the program. Additional hypothesis include home whether exercise interventions can: - be delivered without any associated serious cardiac events; - will result in a decreased proportion of patients who are categorized as frail when compared to the cohort's pre-test baseline. - will result in increased measured peak oxygen consumption when compared with their pre-intervention baseline. - will result in increased step counts measured monthly from baseline to end of intervention - will improve self-reported quality of life from baseline to post-intervention. - will result in increased patient reported activity level from baseline to post-intervention

NCT ID: NCT03687008 Completed - Clinical trials for Single Ventricle Heart Disease

Cognitive Intervention to Improve Working Memory

Start date: June 10, 2021
Phase: N/A
Study type: Interventional

Adolescents with single ventricle heart disease (SVHD) (10 males and 10 females) with mild to moderate cognitive impairment will participate in a total of 25 computer-based working memory training sessions, each 30-40 minutes (5 days a week for 5 weeks) supervised by a trained coach. Primary objective is to evaluate the impact of the Cogmed intervention on working memory scores and the secondary objective to assess brain tissue changes with magnetic resonance imaging (MRI) using diffusion tensor imaging (DTI) techniques, measures of mean diffusivity pre- and post-intervention.

NCT ID: NCT03430583 Active, not recruiting - Clinical trials for Single Ventricle Heart Disease

Evaluation of Fontan-Associated Liver Disease

FALD
Start date: February 20, 2018
Phase:
Study type: Observational

A study to evaluate the efficacy of MZ101 therapy in reducing liver stiffness.

NCT ID: NCT02741115 Completed - Clinical trials for Single Ventricle Heart Disease

Fontan Udenafil Exercise Longitudinal Assessment Trial

FUEL
Start date: July 22, 2016
Phase: Phase 3
Study type: Interventional

This study will evaluate the clinical efficacy and safety of udenafil, an orally administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of adolescent subjects who have undergone the Fontan procedure.